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. 2016 Mar 15;2016(3):CD010570. doi: 10.1002/14651858.CD010570.pub2

Debaty 2014.

Methods Parallel‐group, randomized trial, February 2009 to August 2012, multicentre study
Participants Total number of participants 245, mean age 67 years, 29% female, patients' average temperature at randomization: pre‐hospital cooling group 35.2°C, hospital cooling group: 35.4°C (estimated from graph)
Inclusion criteria:
  • OHCA participants over 18 years of age eligible for advanced life support were included irrespective of rhythm


Exclusion criteria:
  • participants with trauma

  • participants with haemorrhage

  • participants with asphyxia

  • participants already hypothermic (temperature < 34°C)

  • women who were obviously pregnant

  • participants who had achieved ROSC before randomization

  • participants with a do‐not‐attempt resuscitation order

Interventions Intra‐arrest cooling, infusion of up to 2000 mL of ice‐cold 0.9% saline solution at 100 mL/min during cardiac arrest by use of a standard infusion set and a pressure bag inflated to 300 mmHg. Surface cooling was also induced using gel pads.
Outcomes Types of outcome measures:
Primary outcomes
  • neuron specific enolase (NSE) at 24 hours


Secondary outcomes
  • IL‐6 concentrations during the first 72 h

  • IL‐8 concentrations during the first 72 h

  • IL‐10 concentrations during the first 72 h

  • cooling rates

  • ROSC rate

  • length of stay in intensive care

  • survival (discharge, 30 days and 1 year)

  • neurological outcome comparing individual CPC scores (hospital discharge and 30 days)

Funding French Society of Emergency Medicine
Declarations of interest None
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization assignments were generated under a randomized permuted‐block design, with block sizes of 4, in a 1:1 allocation
Allocation concealment (selection bias) Low risk Each mobile intensive care unit was given sequentially numbered, sealed envelopes containing single randomization assignments
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information provided
Blinding of outcome assessment (detection bias) 
 Good neurological outcome Low risk Neurological outcome at hospital discharge and 30 days was assessed by a physician blinded to the study allocation
Blinding of outcome assessment (detection bias) 
 Survival Low risk Lack of blinding of survival data considered 'low risk'
Blinding of outcome assessment (detection bias) 
 Adverse events Unclear risk Not stated
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Analysis of clinical outcomes was according to intention‐to‐treat
Selective reporting (reporting bias) Low risk All expected outcomes included
Other bias Unclear risk No information on application of pre‐hospital cold fluids (which proportion of patients received how much)
Over 24 hours of cooling the body temperature of the intra‐arrest cooling group seemed to be higher than the body temperature of the hospital cooling group
According to the authors the study was not powered to show a clinical difference